Efficacy of Transarterial Chemoembolization With DC-BeadsR Prior to Liver Transplantation for Hepatocellular Carcinoma on Patient Survival : A Prosepctive Multicentre and Randomized Study
- Multicentre, prospective, randomized, 2 parallel group study
- Preoperative evaluation of hepatocellular carcinoma in recipients: Tumor diagnosis will
be mainly based upon EASL guidelines. HCCs will be classified according to UCSF
criteria (size, number of nodules). Clinical and biological status will be updated
every 3 month.
- Pre-transplant treatment:
TACE group: An emulsion of Lipiodol and a cytotoxic drug (50mg/m2 of doxorubicin) will be
injected as selectively as possible. Then, an embolic agent will be used to assure stop of
flow. The first injection will be performed within 10 days following enlisting and repeated
every 8 weeks until LT (only if hypervascularized vital tumor tissue is again visible on CT
Scan and if liver function remains within Child A stage) or until complete response.
Clinical/biological follow-up will be done once a month.
Control group (no treatment until LT): clinical/biological follow-up and CT-scan every 3
This prospective, multicentric, and randomized study may allow investigators to show that
TACE with DC-BeadsR can significantly increase intention to treat survival of patients
transplanted for HCC. We also expect that this result will be associated with less
recurrence of the cancer after transplantation.
Obviously, we expect that the beneficial effect of TACE will be associated with a acceptable
rate of complication related to the procedure.
- Pathologic examination: In all patients in whom LT will be performed, the diagnosis of
hepatocellular carcinoma will be confirmed by a histological examination of the
- Dropout criteria: Patients with progression but still meeting the transplant criteria
will be maintained in their respective group. Patients with progression over the
transplant criteria will be excluded from the waiting list and censored.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intention to treat survival at 3 years following inscription on the waiting list for liver transplantation in patient with hepatocellular carcinoma
Philippe COMPAGNON, MD
Service de Chirurgie Digestive - Transplantation Hépatique / Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris / Faculté de Médecine - Université Paris-Est
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)